The present invention relates to excision of a section of a hollow or tubular soft organ, such as the digestive tube, and rejoining the remaining ends and, more particularly, to methods for performing these operations under conditions of closed surgery, using a flexible annular stapling and cutting instrument. The invention also relates to an improved construction of such an instrument.
Various ailments of the digestive tube, particularly of the esophagus, the stomach, the small intestines and the colon, such as tumors, chronic inflammation or other disorders, often require excision of a portion of the tube, followed by rejoining of the remaining end segments, through anastomosis, to reestablish continuity of the tube. In some cases it is necessary to thus join one organ to another; for example, the cut end of the small intestines may be joined to the colon, or the cut end of the duodenum may be joind to the stomach. In some other cases, two organs or two portions of the same organ may be joined side-to-side (rather than end-to-end or end-to-side, as in the above cases). In the discussion to follow and in the claims, the terms "parts of hollow organs" or just "parts" will be used, for brevity, to collectively denote the two parts to be joined, and the terms "part of a hollow organ" or just "part"--to denote each of the two parts to be joined, whether they are truly two different hollow organs or two segments of the same hollow organ.
It has been common practice since the end of the '50s to use, for the purpose of the anastomosis, a suitable annular stapling and cutting instrument. An example of such an instrument, to be referred to herebelow as stapler, is depicted in FIG. 1A. The stapler basically consists of a tubular main body, at one end of which is an annular staple gun, while the other end serves as a handle and has a knob and activation levers thereon. A rod is slidably disposed inside the tubular body, protruding through the staple gun and terminating with a round head that contains an annular anvil. The staple gun contains a set of surgical stapling pins, arranged in one or two concentric circles and a circular knife inside these circles. On the face of the anvil are short grooves, one opposite each staple pin, with arc-like depth profile. During surgery, this stapler is used, for example, to rejoin end segments of the intestines after excision, by inserting it through a longitudinal cut in the side of the intestines and through the ends of both segments, then annularly folding and temporarily sewing one end over the face of the gun and one end over the anvil; the latter operation forms the ends into partially closed flange-like butts. Subsequently, by turning the knob, the head with the anvil is pulled toward the face of the gun, thus bringing the butts into mutual contact. Finally, by activating a lever on the handle, the staple pins are pushed through the flanges into the grooves in the anvil until they are bent tight; at the same time, the circular knife cuts away the inner disks of the two adjoining flanges, leaving an annular ring as the joint.
This, conventional, type of stapler has several shortcomings:
It always requires an extra, longitudinal, cut; for multiple excisions, multiple extra cuts are needed. PA0 It is not suitable for hard-to-reach or complicated portions of the intestiness, such as those inside the pelvis, nor for the duodenum; operation on the esophagus or the stomach is difficult. PA0 It is suitable almost only for end-to-end joints. PA0 The temporary sewing of the butt ends is difficult and the depth of the resulting flanges is small, thus risking leakage. PA0 (a) an elongated flexible tubular body; PA0 (b) a handle attached to a first end of the body; PA0 (c) a first jaw having an axial hole therethrough and two faces, a first face being attached to the second end of the body; PA0 (c) a flexible cable slidably disposed inside the body and through the hole, the cable consisting of two portions, a first portions defining an end segment, at least part of which protrudes from the second face of the first jaw; and PA0 (d) a second jaw, defining a head, being attachable to the end segment; PA0 (i) a housing attached to the second end of the body, PA0 (ii) an elongated externally threaded member disposed inside the housing and attached to the second portion of the cable, PA0 (iii) a turning assembly, which includes an internally threaded member that engages the externally threaded member, and a knob outside the housing, and PA0 (iv) a lever assembly, which includes a manually pressable lever; PA0 (a) providing a flexible annular stapler having two round jaws; PA0 (b) inserting the jaws into a first one of the two parts and advancing the jaws to where one jaw is inside the first part and the other jaw is inside the second one of the two parts, each jaw being substantially near the respective plane; PA0 (c) for each of the two parts, shrinking the opening so as to form an at least partially closed butt that encloses the respective one of the jaws; and PA0 (d) operating the annular stapler so as to pull the two the butts together and essentially combine the two annular areas into a combined annular area, to staple the two organs or segments to each other over the combined annular area and to cut away portions of the butts that are central to the combined annular area. PA0 (a) providing a flexible annular stapler having a flexible body, two round jaws and a flexible cable slidable through the body and through a first one of the jaws and having an end protrudable from the first jaw, the first one of the jaws being attachable to the body and the second one of the jaws being attachable to the end of the cable, both of the jaws being initially detached; PA0 (b) inserting the flexible body through the patient's body wall; PA0 (c) introducing the first jaw through the patient's body wall and attaching it to the flexible body; PA0 (d) introducing the second jaw through the patient's body wall and attaching it to the end of the cable; PA0 (e) having the first jaw inside the first one, and the second jaw inside the second one, of the two parts of hollow organs and having each of the two parts form an at least partially closed butt at or near the respective plane, the butt enclosing the respective one of the jaws; and PA0 (f) operating the annular stapler so as to pull the two butts together, to staple the two organs or segments to each other over an annular area and to cut away portions of the butts that are central to the annular area.
French patent FR 9204490 to the present applicant, which is incorporated into the present disclosure by reference, discloses a novel annular stapler that differs from the one described hereabove essentially in the following (see FIG. 1B for an external view and FIG. 1C for a longitudinal-sectional view): The main, tubular, body consists of a flexible hose 26, which can be of any length and to one end of which an anvil assembly 18 is attached. Through hose 26 is slidably disposed a flexible cable 21, one end of which is pointed and to which a head 11 is attachable. The other end of cable 21 is attached to a handle 30 by means of a long screw 52, engaged by a nut 51, which is connected to a knob 46 so that turning the knob causes the cable to slide along the hose and thus--the head to move with respect to the anvil. The head contains a cartridge with staple pins and a rigid hammer assembly 15 (to be refrred to as hammer) that includes fingers, to push the pins, and a circular knife. Hammer 15 is connectable to the end of cable 21 by a screw-like arrangement. Connected to the hammer through a spring is an annular base plate, which holds the cartridge of pins and has slots for passage of the pins. Cable 21, which may be hollow, has a flat outer surface, which matches a flat in the shape of a central hole in anvil 18 through which the cable slides; this is in order to keep the head angularly aligned with respect to the anvil prior to stapling. In handle 30 there is a window 54, through which a millimeter scale 42, attached to cable 21 is viewable, together with a fixed pointer. Operation of this stapler is similar to that of a conventional one, except that the stapling and cutting operation, after the two butts have made contact, is actuated automatically by continued turning of the knob (rather than activating a lever.
This novel stapler avoids the shortcomings of the conventional one, listed hereabove. In particular, it enables reaching any segment of the digestive tube--either through a natural opening (mouth or anus) or through a single, conveniently located cut. It also enables end-to-side or side-to-side joints.
Even so, the novel stapler of French patent FR 9204490 (to be referred to as the French patent) still has a few shortcomings and many as yet unrealized potentialities. One shortcoming is that in the disclosed construction there is an appreciable length of cable between the point at which the cable emerges from the anvil and the point at which it enters the head structure, even when these two components are at their closest approach. This may allow some twist in the cable and consequently some angular misalignment between the staple pins in the head and the grooves in the face of the anvil, which may cause malfunctioning of the stapling action. Likewise, because of uneven back pull of an intestinal butt, the faces of the two components may not be parallel, or may not be axially aligned prior to the stapling action, which, again, could cause malfunction. Another shortcoming of the instrument is in the operation of the handle; turning the knob may not be the optimal way to activate the stapling and cutting operation. Yet another shortcoming is the difficulty with which the head or anvil are are attachable or detachable, making such operations within the body, as would be advantageous in certain procedures, close to impossible.
The unrealized potentialities are mainly associated with a new possible mode of its employment, a mode that was not contemplated in the French patent but is the subject of the present invention, namely closed surgery. The practice and techniques of closed surgery, such as laparoscopy and thoracoscopy, have made tremendous progress over the past five years and many surgical procedures on internal organs are now carried out in this mode. Whereas in conventional, open, surgery, a relatively large incision is made in the abdominal wall or chest, closed surgery is characterized by insertion of very thin tools through otherwise intact walls--usually with the aid of small tubular ports, called trocars, which also serve to seal the openings during operation. Some of these tools serve for viewing and usually include a video system so that the entire operation is viewed and monitored on a video screen. The main advantages of closed surgery are (a) the much reduced trauma, resulting in fewer complications and much faster recuperation, which, in turn, shortens hospitalization and costs, (b) reduced risk of infection and (c) considerable reduction of scars.
Closed surgery of the digestive tube is also being practiced. However, because the only practical instrument now available for anastomosis is the rigid type described hereabove, which has to be operated under open conditions, the surgery ends up being, in part, of the open type (such as laparoscopically assisted surgery) and thus foregoes some of the advantages listed above. Basically, a flexible stapler, as described hereabove and contrary to a conventional, rigid, stapler, lends itself to completely closed surgery (such as laparospcopy and thoracoscopy), since the instrument is insertable either through the natural openings or through a suitable opening in the intact wall and can reach almost any location. However, such use of a flexible stapler has not yet been attempted nor, to the best of the inventor's knowledge, even been suggested. Moreover, there are certain aspects of this type of surgery that render direct utilization of the instrument, as disclosed in the French patent, difficult or impractical. For example, the preliminary circular sewing of the butt ends over the instrument's head or anvil, difficult even during open surgery, is close to impossible. Under certain circumstances it is preferable to place the active part of the instrument in the affected area prior to excision; it is then difficult to sense its position within the intestines. Also, there is a need for endoscopy during the operation and it may be difficult to insert or manipulate both the endoscope and the flexible stapler simultaneously in the same tube. A similar difficulty holds for internal ultrasonic examination.
Since, as stated, use of a flexible stapler in closed surgery has not yet been attempted and since, moreover, such an instrument is not yet available, there has been no clinical experience with anastomosis in the digestive tube under conditions of closed surgery and certainly no experience using such an instrument. Thus, no suitable procedures have so far been developed, which fact keeps the clinicians and patients from benefiting from the tremendous potential advantages of the technology and also hinders potential acceptance by clinicians of the instruments when they become available.
There is thus a recognized need for, and it would be highly advantageous to have, an improved stapler for anastomosis in the digestive tube that will overcome the shortcomings of presently known instruments and will, moreover, enable such operation under conditions of closed surgery. There is, furthermore, a need for practical methods and procedures for utilizing such an instrument under conditions of closed surgery.